Full Study Title:  An Investigator-Initiated Phase 3 Multicentre Open-Label Blinded-Endpoint Randomized Controlled Trial to Evaluate the Efficacy and Safety of Very Low-Dose Anticoagulant Therapy (Edoxaban 15 mg Once Daily) Added to Standard-Care Single Antiplatelet Therapy for Enhancing the Prevention of Fatal and Non-Fatal Recurrent Strokes, and Associated Disability and Dementia, in At-Risk Participants with Ischemic Stroke Aged 75 Years or Older (STROKE75+) 

Sponsor: Sunnybrook Research Institute

Study Contacts:

For study-related questions or emergency contact numbers:

Dr. David Gladstone (Study PI): 437-424-3636 or david.gladstone@sunnybrook.ca

Backup contacts:

Randi Elituv (Research Nurse Coordinator): 416-820-3829 or randi.elituv@sri.utoronto.ca

Amanpreet Kaur (Research Coordinator): amanpreet.kaur1@sri.utoronto.ca

Dr. Richard Swartz (Study Co-PI): 416-727-3281 or rick.swartz@sunnybrook.ca

For more information, see: ClinicalTrials.gov [ID# NCT07454707]

https://clinicaltrials.gov/study/NCT07454707?cond=%22Stroke%22&aggFilters=status:not%20rec&viewType=Card&term=stroke75%2B&rank=1

Brief Summary:

The overall aim of this research is to improve secondary stroke prevention for older patients with stroke.

In current practice, patients with stroke are often prescribed antiplatelet therapy with either aspirin or clopidogrel to help prevent recurrent strokes. However, an antiplatelet medication may not be effective enough for some patients.

A promising new treatment strategy to enhance stroke prevention involves a very low dose of an anticoagulant (anti-clotting medication) added to the standard antiplatelet therapy. In a previous study, this approach cut stroke risk in half among patients with heart/vascular disease, but it has not yet been formally tested in an older stroke population. The STROKE75+ trial is now being conducted to carefully evaluate the potential benefits and potential risks of this type of treatment strategy for secondary stroke prevention.

The medication being tested in the STROKE75+ trial is a commonly used anticoagulant called edoxaban -- at a reduced dose of 15mg once daily (one-quarter of its full dose) to minimize the chance of bleeding. In previous research, edoxaban 15mg daily has been shown to be safe and effective for preventing strokes in patients with atrial fibrillation, but it has not been studied in stroke patients without atrial fibrillation.

This trial aims to answer the following questions:

1. Does the addition of edoxaban 15mg once a day to standard antiplatelet therapy reduce the risk of recurrent strokes more than standard antiplatelet therapy alone?

2. Does the addition of edoxaban 15mg daily reduce the risk of severe (disabling) strokes, dementia, or heart attacks?

3. What is the incidence of bleeding with/without edoxaban 15mg daily?

These questions will be addressed using a Randomized Clinical Trial design. Eligible participants are randomly assigned (50/50 chance) to one of two study groups. Participants in Group 1 are treated with edoxaban 15 mg once a day by mouth (tablet) in addition to their usual standard antiplatelet medication. Participants in Group 2 will continue to take their standard antiplatelet medication (aspirin or clopidogrel) without edoxaban.

Participants are monitored closely for the duration of the study (approx.. 2-4 years). Every 3 months, participants will receive a phone call to check on their health status and assess if they have experienced any new strokes, bleeding, or other medical problems. Once a year, and at the start and end of the study, participants will also be asked questions about their symptoms, functioning, memory, and quality of life. At the end of the study, patient outcomes between the two groups will be compared and the results will be published.

The information gained from this study will increase knowledge and help inform future stroke care for the aging population. The ultimate goal of this research is to prevent more strokes, save lives, and reduce the growing public health burden of stroke.

Eligibility checklist  (Uploaded as a PDF file)